In today's world the average person is living longer. What is more important, though, is that people are trying to enjoy life in later years like never before. This places demands on new, enhanced medical technologies to support these new lifestyles and increasing expectations. One area of increasing interest is the need for better diagnoses of the human back. Studies show that approximately 60% to 80% of people living in Western societies experience back pain at some point in their life. In many cases, however, the exact source of the pain is often not clear, even with the best diagnostic methods. This presents a dilemma for the orthopedic surgeon who is about to operate or prescribe a therapy.

Back pain is as much part of the human condition as the common cold. In fact, eight out of ten adults may experience an acute episode of back pain at some point in their lifetime. Back pain is the second most common cause of missed workdays due to illness and is the most common cause of disability in the United States. While most cases of back pain are limited, 5% to 10% of these cases will become chronic. Those chronic conditions account for 90% of the health care expenditures for back pain and amount to over $100 billion annually in the U.S.

Many different elements in the back or neck are capable of producing pain. There are several large nerve roots that go to the legs and smaller nerves that innervate the body. In the case of acute pain, the large paired back muscles may be strained, or the bones, ligaments and joints of the back may be damaged. In general, pain does not mean that there is actual tissue damage. Even if the pain is severe, there rarely is on-going tissue damage. Most pain symptoms are due to inflammation, especially in the acute phase, which typically lasts for two weeks to three months.

Typically, younger individuals (30 to 60 year olds) are more likely to experience back pain from the disc space itself (e.g. lumbar disc herniation or degenerative disc disease.) Older adults (60 years and above) tend to suffer from degeneration of the joints of the back (e.g. facet joint osteoarthritis.) To date, there are no effective methodologies to address and diagnose chronic back pain. Although CT and MRI are widely used, they are not effective in diagnosing several chronic back pain areas. In many cases, the exact source of the pain is not clear, even when using the best radiological equipment. This presents a need for additional information for the radiologists, who, together with the orthopedic/neurosurgeon, are the providers of treatment options to patients.

The standard MRI/CT examination process is performed in Psoas Relaxed Position ("PRP"). This is not effective in numerous cases of chronic back pain, as the patient is lying down and free from the effects of gravity and body weight on the stressed joint or inflamed area. The ideal way to look at patients with a degenerative or chronic back condition is in a standing position or "loaded" position that is known as an Axial Compression Extension ("ACE").

Over the past 20 years, there have been attempts at creating devices that will allow the examination of chronic back pain patients in the ACE position. Until now, there existed three major obstacles to creating such a device, which include: (1) the difficulty in accurately replicating the ACE position in a measurable, uniform, repeatable fashion; (2) the fact that magnetic metal objects cannot be used in conjunction with MRI examinations as they become projectiles, thereby limiting the use of any magnetic metal type of device; and (3) the lack of clinical data supporting the use of such a device and illustrating significant diagnostic improvement.

According to several studies published (see Scientific Presentations and Articles), DynaWell L-Spine considerably increases the accuracy in MRI and CT spinal examinations, and better assists medical professionals in the accurate diagnosis of a multiplicity of chronic back pain conditions. DynaWell's paradigm is to create a series of devices that will simulate the ACE process for examination in several diagnostic areas.

Included below are some facts as reference points for the size and nature of back pain problems:

Back pain is a leading cause for health care expenditures in the United States, with more than $100 billion in annual direct and indirect medical expense.

Back pain is the principal reason for doctor visits in the United States, and back pain affects more than 10 million people annually.

Back pain is the principal ailment cited in worker's compensation claims in the United States.

Back pain is the principal cause of employee absenteeism in the United States.

About 35% of all orthopedic hospital admissions are spine related.

There are approximately 7,500 orthopedic spine surgeons and neurosurgeons practicing worldwide.

More than 220 spinal conditions, indications, and pathologies afflict patients throughout the world.